INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07296211
Status
Not Yet Recruiting

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Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CHW-enabled CCL — BEHAVIORAL
    The FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.
  • Mobile health (mHealth) diabetes self-management education and support (DSMES) videos — BEHAVIORAL
    Participants will receive 24 culturally tailored DSMES videos through text message.

Study Details

The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.

Key Dates

Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos
    For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will receive 24 culturally tailored diabetes education videos via text message.
  • Experimental: Patients in a CHW-enabled clinic that do not receive mHealth videos
    For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will continue to receive standard of care (SOC).
  • No Intervention: Patients in a standard clinic that do not receive mHealth videos
    For 12 months participants will be followed as they receive SOC from their clinic.

Primary Outcome Measure

Change in HbA1c levels [ Time Frame: Baseline, Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY